Saturday, February 9, 2008

Wall Street Journal Picks up Sloan-Kettering Story

Jacob Goldstein and the Wall Street Journal Blogran the story on Sloan-Kettering's decision to ban industry funding of CME and generated an entertaining debate in the comments section. I recommend that interested readers take a peek. You'll find the usual polarities in this contentious topic, including both those who cheer on Sloan-Kettering for its ethical stand, and those who warn that this is a dangerous trend and will lead to poorly educated doctors.

But my favorite comment was posted by "Get Real CME Companies," a person who has worked in the CME system for 20 years. The writer's description of how porous the so-called firewall is between drug companies and the "independent" medical education companies that produce the CME is so accurate and trenchant that I can't resist reprinting it below in its entirety:

"I love all the comments by the CME vendors about how great the system is and how the rules require independence. I have never read such a load of crap in my life. Yes, the rules require independence. Who enforces it? If you work in CME you know the answer very well NO ONE. As the recent investigation by the Senate Finance Committee found the ACCME has no teeth whatsover. But more importantly, the rules are loosely structured and basically an entire approach has developed that works around the rules. And it’s not very sophisticated but certainly very devious. Marketing teams will generate a list of medical topics they think are important, things that they supposedly get questions about. Inevitably, certain off-label uses of their product will be on the list because as I said of course they get lots of questions about that. That list of questions or topics will be used by the companies grants department to award grants. Now the CME vendors are very smart folks, it’s an incredibly profitable business. They will submit grants and they will note in the request who the chairperson of the event will be and inevitably it will be the lead investigator from a hot off-label study. It’s a shocker but that grant request will be awarded while hundreds of others will be rejected. So the CME vendors learn over time what exactly they need to do to get the money. Pharma companies don’t need to exercise any control. All the control they need happens right up from when the grant decision is made. It’s a giant game incredibly profitable for pharma and the CME vendors alike. And there is no one minding the store. I have worked in this area for 20 years and what I have seen happen in that time frame makes me sick. CME has become just another marketing tool. Many of the CME vendors are the same companies who do the marketing programs, they just have a CME arm! I applaud Sloan-Kettering. And I applaud this blog for picking it up. I frequently look at about 4 or 5 different pharma related blogs and did not see this anywhere. It’s a great development and I hope it sets a trend. Pharma and CME have had too many years to clean up their act. It’s time for more dramatic change. Please keep focused on this story, it’s huge."

to Memorial Sloan Kettering Cancer Center, Ethics Committeefrom: a concerned citizen!Please clarify Sloan’s policies relative to the following Conflict of Interest [COI]/ethics issues: On occasion [e.g. when an article appears in the lay press] an intuitive (and persistent cancer) patient (or their proxy) accesses the Bioorganic Chemistry Laboratory via phone, seeking information about (and participation in) epothilone clinical trials conducted at MSKCC. In the past the non-clinician Ph.D. Administrative Manager [AM] (Dr. Sarah Danishefsky, the spouse of the Principal Investigator [PI, also a Professor of Chemistry at Columbia University]) of the high profile Bioorganic Chemistry Laboratory has instructed me (a junior, but not direct report) to keep secret (withhold/embargo) known information relative to the availability of clinical trials conducted at MSKCC on a (Bristol Myers Squibb [and/or possibly Novartis’] developed epothilone derivative) drug candidate(s) that compete(s) directly with an epothilone analogue candidate that emanates from the Bioorganic Chemistry Laboratory, in variance with the above-mentioned queries and the fact that the AM had actually apprised me that a clinical trial on the competitor’s drug candidate(s) was or were commencing (or had commenced) at Sloan and then instructed me to embargo this information. The AM subsequently attempted to cloak her motives by stating “ours are better than theirs,” invoking early, at that point unverified comparative in-vitro and/or in-vivo data points (supplied by a colleague whose scientific methodology had been questioned on more than one occasion by disparate, mutually exclusive researchers, (grant and other) administrators and/or industrial courtship candidates who did not know of each other’s concerns about the Sloan colleague researcher). At that point in time the Bioorganic’s candidate was ~ an estimated 1 year from the start of a proposed and hoped for clinical trial (which has apparently since begun [off site, and possibly at Sloan]). The lab had smarted, being bested (and dropping out of a front-runner position) in a high profile natural product synthesis race when a staff process chemist charged with supplying an already solved piece of the puzzle reportedly used the wrong racemer of a reagent that was not checked appropriately by the A team prior to utilization, dooming an otherwise successful virtually complete synthesis to failure. Germane is a financially significant, development / rights purchase of a Bioorganic Laboratory epothilone drug candidate by Roche via Kosan (its licensee) [since abandoned by Roche]. Although one can understand the premise of not promoting a competitor’s product, that business tenet would clearly not be applicable in this situation at Sloan. Though I have been warned on more than one occasion to not report these problems by Sloan employees I’ve felt uncomfortable misleading seemingly desperate cancer patients or their proxies and I have always referred these queries to either the MSKCC Physician Referral help line or to administrators or nurse clinicians affiliated with the clinician under whose aegis the BMS [and/or possibly the Novartis] trial (and possibly, now, the Bioorganic candidate’s study) is apparently conducted at Sloan) for proper vetting. That the Administrative Manager would place her own potential financial successes and results above the content of the character of the Sloan-Kettering Institute does not surprise me. That she instructed (and expected me) to abet this initiative was out of line and evidence of a lack of respect for the Institute and for myself. I did not think that the AM would go so low as to expect me to do her dirty work or to drop her guard to the point that she’d expose herself, the lab and Sloan to this type of ethics liability, considering that the Bioorganic compound(s) might very well prove to be the best of the epothilone class, after proper clinical trial vetting. Such a tack, if followed would be in variance with that espoused [by Varmus, Nurse, Mendelsohn and/or Abeloff] on the “Titans of Cancer” television special. My parent’s first child died of complications from childhood leukemia at Memorial Hospital two years before I was born. A child with this affliction today stands a good chance of survival due in no small part to the therapeutic advances fomented at Sloan and other like-minded Institutions, yet if the above-mentioned bio-ethically challenged tack were allowed to continue unchecked, it would tarnish the otherwise important science and medicine that emanates from MSKCC and instead of properly steeling hope, Sloan Kettering would merely be stealing hope, one clinical trial enrollee at a time. There is a difference between proudly standing behind one’s brilliant work product and bending the rules when convenient for oneself, especially when lives may be in the balance and when the professionals bending rules are people and/or Institutions who clearly know better and who claim to be standard bearers of higher ethical practice. A US Army General (possibly a War-College dean/affiliate) has stated (I paraphrase) that Harvard MBA candidates learn to overcome ethics while pursuing a profit. Such an MO may be in variance with the COI and ethics policies of MSKCC. The above mentioned instance of craven self-servitude is coupled with other episodes of intermittently palpable disingenuousness at Sloan (e.g. that the AM is considered a “full time” employee, yet is often on campus at most perhaps 50% time and has had the temerity to complain during work hours via phone from off-campus that she could not check her stocks, peculiar acts of self promotion (e.g.: arranging for one’s own nomination for scientific accolades and acting surprised and naive when awarded them, including a prize from the very company [BMS] on the short end of the AM’s conflicted interest), a protégé professor who fellowshipped in the Bioorganic Lab involved in his own hubris inspired imbroglio (retraction of multiple tenure facilitating papers and allegations of having an affair with a student and of her “irreproducible” data); the Bioorganic PI had reportedly been barred from consulting at a branch of a NJ based major pharmaceutical company, concerns about the efficacy of laboratory notebook record keeping and the egregious physical plant shortcomings at the Institute (a confluence of bizarre design, building/construction and facilities management flaws in the RRL laboratory building that intermittently, inappropriately render the RRL a toxic firetrap [whose cover-up (and the ruse invoked while duping a rightfully concerned local community, the community board and the city relative to systemic infrastructure problems in the RRL and safety issues at MSKCC that affect employee and community safety) allowing for the hurdling of impediments to the construction of the new/replacement Sloan research tower and the granting of a zoning variance has included the conjuring and synchronizing of cover stories (as well as threats against employees who appropriately report environmental health and safety (EH&S) problems at Sloan) by MSKCC (facilities management and other Sloan administrators). Sloan had to previously abandon a building due to facilities/infrastructure problems that allowed for its employees to be exposed to unsafe levels of poisonous carbon monoxide]; these and other infrastructure problems affect reaction conditions and therefore stand to impeach the credibility of research conducted at Sloan (e.g.: cross contamination between supposedly mutually exclusive fume hoods and ductwork whose controls were unfathomably, yet knowingly, not installed properly by MSK). It has also been reported that the PI of the Bioorganic Laboratory has attempted to leverage (to the point of irritating) the clinician overseeing clinical trials at Sloan to continue and/or increase enrollment in a trial of the above-mentioned bioorganic drug candidate in variance with the clinician’s concerns about the bioorganic drug candidate’s efficacy and patient safety. This is significant because very large milestone dependent royalty payments are contingent upon continued enrollment of patients and/or completion of a clinical trial’s “Phase.” A high profile researcher/clinician (a deputy physician in chief) at Sloan has been arrested following an SEC investigation for insider (Imclone) stock trading; The former physician in chief committed suicide; Off-scale windfall profits have been available to biotech company insiders at Sloan, perhaps their fortunate tipees (e.g.: Ariad [stock ticker: Aria] whose stock price jumped one hundred (100) times or ten thousand (10,000) percent during a relatively short ~ five (5) month period (10/99-3/00) following assuaging of a “buy” impediment [the former Director of the Central Intelligence Agency, pardoned by President Clinton, has sat on the Board of Ariad]) and perhaps fortunate future tipees, were this type of lightning to strike again. Although the honest application of the forces of commerce (monetary reward for brilliant and properly vetted hard work) are appropriate, inappropriate leverage by a powerful non-clinician possibly resulting in someone being a pawn so that the non-clinician or the Institute could receive a royalty payment that lay in the balance, or the embargoing of known information about the availability of competitors’ clinical trial drug candidates are likely not. Congress has investigated the National Institutes of Health (NIH) relative to ethics/conflict of interest concerns (e.g.: the National Cancer Institute’s (NCI’s) erstwhile Director). So who’s minding the store and who can a desperate cancer sufferer trust if the guardians are equally or more concerned with their own stock portfolios than patient safety and drug efficacy? Some of these issues have been broached in the New York Times, The New York Observer, other press publications and even Michael Moore’s movie “Sicko.” For the protection of the Institute, in these times of heightened corporate, medical and pharmaceutical industry scrutiny and accountability, given that the research conducted in the Bioorganic Chemistry Laboratory is funded in part by government (e.g.: NIH RO1 [discovery] and RAID [scale-up for industrial development (the NIH researcher/administrator who vetted the Sloan epothilone candidate prior to award of an NIH RAID grant has since sat on the Board of Kosan)]) grants and philanthropic (e.g.: MSKCC Major Donor) sources and that MSKCC is reviewed (and accredited) by the Joint Commission on Accreditation of Hospital Organizations (JCAHO), please clarify Sloan’s policy relative to the ethics/conflict of interest awkwardness discussed in this note. One ought to be wary whether a greeting offered by Sloan to a cancer sufferer (especially one who is recruited to join a [lab to clinic] “translational” experimental study) is a compassionate smile or a smirk and whether Sloan is a leader in the fight against cancer or merely a cog in the “cancer racket.” There is a connection between the EH&S and ethics problems as potential and/or realized profit has affected the non-addressment of systemic environmental health and safety issues at Sloan. Has Sloan conjured and synchronized their cover stories relative to these issues as MSKCC has done in the past relative to other white-washes for which Sloan “conducted its own investigation” (eg: EH&S, “drug dealing” in its basement [the General Stores (GS) takes up a large portion of the MSKCC basement and one must be concerned as to if and how extensively the GS were compromised [and if government subsidized products or patient safety were compromised])? Is MSKCC following the Hippocratic or Hypocritic Oath? The PI of the lab discussed in this note has in the past been ‘predicted’ to win the Nobel Prize, see: http://scientific.thomson.com/press/2007/8407285/ People and Institutes capable of performing this level of science clearly know better than to act this way, especially when it is clearly not necessary. Shame on you! How dare you!